Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis - Full Text View

Sponsored by:	NeoStrata Company, Inc.
Information provided by:	NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:	NCT00769184

Purpose

This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.

Condition	Intervention
Psoriasis	Drug: clobetasol + LCD Drug: Clobetasol + Placebo

MedlinePlus related topics: Psoriasis

Drug Information available for: Corticosteroids Clobetasol Clobetasol propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study.

Further study details as provided by NeoStrata Company, Inc.:

Primary Outcome Measures:

Proportion of patients who are clear (PGA score 0) or have minimal disease (PGA score 1) on each treated side at each visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in disease severity (using PGA score, erythema, scaling, induration, and overall severity scores of target lesions, %BSA involvement, and patient self-assessment of psoriasis symptoms) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)	Drug: clobetasol + LCD clobetasol: 2 applications / day LCD Solution: 2 applications / day
2: Placebo Comparator steroid + placebo treatment (2 weeks), placebo alone treatment (4 weeks)	Drug: Clobetasol + Placebo Clobetasol: 2 applications / day Placebo Solution: 2 applications / day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
able to provide written informed consent
able to attend study visits, apply medications, and follow instructions
moderate to severe localized plaque psoriasis lesions (<10% BSA on each side of the body)

Exclusion Criteria:

other current treatments for psoriasis
hypersensitivity to steroids, liquor carbonis detergens, alcohol, fragrance
pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769184

Contacts

Contact: Jerry Bagel, MD

(609) 443-4500

njpsoriasis@aol.com

Locations

United States, New Jersey
Windsor Dermatology	Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Jerry Bagel, MD 609-443-4500 njpsoriasis@aol.com
Principal Investigator: Jerry Bagel, MD

Sponsors and Collaborators

NeoStrata Company, Inc.

More Information

Responsible Party:	NeoStrata Company, Inc. ( Barbara Green )
Study ID Numbers:	08-LCDSTRD
Study First Received:	October 7, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769184
Health Authority:	United States: Institutional Review Board

Keywords provided by NeoStrata Company, Inc.:

chronic plaque psoriasis

Study placed in the following topic categories:

Clobetasol
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009